Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - dicloxacillin sodium, quantity: 271.26 mg (equivalent: dicloxacillin, qty 250 mg) - capsule - excipient ingredients: silicon dioxide; magnesium stearate; gelatin; titanium dioxide - dicloxsig is indicated in the treatment of confirmed or suspected staphylococcal and other gram positive coccal infections, including skin and skin structure and wound infections, infected burns, cellulitis, osteomyelitis and pneumonia. note: benzylpenicillin is the drug of choice for the treatment of streptococcal pneumonia. bacteriological studies should be performed to determine the causative organisms and their susceptibility to dicloxacillin. dicloxsig should not be used in infections due to organisms susceptible to benzylpenicillin. important note: when it is judged necessary that the treatment be initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates the infection is due to an organism other than a benzylpenicillin resistant staphylococcus sensitive to dicloxacillin, the physician is advised to continue therapy with a drug other than dicloxacillin or any other penicillinase resistant penicillin.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

new horizon rx group, llc - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen sodium 550 mg - carefully consider the potential benefits and risks of naproxen sodium tablets, usp and other treatment options before deciding to use naproxen sodium tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. naproxen as naproxen sodium tablets are indicated: naproxen sodium tablets, usp are contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium. naproxen sodium tablets, usp should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings: anaphylactoid reactions and precautions: preexisting asthma). naproxen sodium tablets, usp are contraindicated for the treatment of peri

Stati Uniti - Ingliż - NLM (National Library of Medicine)

proficient rx lp - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen sodium 550 mg - carefully consider the potential benefits and risks of naproxen sodium tablets, usp and other treatment options before deciding to use naproxen sodium tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. naproxen as naproxen sodium tablets are indicated: • for the relief of the signs and symptoms of rheumatoid arthritis • for the relief of the signs and symptoms of osteoarthritis • for the relief of the signs and symptoms of ankylosing spondylitis • for the relief of the signs and symptoms of juvenile arthritis • for relief of the signs and symptoms of tendonitis • for relief of the signs and symptoms of bursitis • for relief of the signs and symptoms of acute gout • for the management of pain • for the management of primary dysmenorrhea naproxen sodium tablets, usp are contrain

Stati Uniti - Ingliż - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen sodium 550 mg - carefully consider the potential benefits and risks of naproxen sodium tablets, usp and other treatment options before deciding to use naproxen sodium tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. naproxen as naproxen sodium tablets are indicated: • for the relief of the signs and symptoms of rheumatoid arthritis • for the relief of the signs and symptoms of osteoarthritis • for the relief of the signs and symptoms of ankylosing spondylitis • for the relief of the signs and symptoms of juvenile arthritis • for relief of the signs and symptoms of tendonitis • for relief of the signs and symptoms of bursitis • for relief of the signs and symptoms of acute gout • for the management of pain • for the management of primary dysmenorrhea naproxen sodium tablets, usp are contrain

Stati Uniti - Ingliż - NLM (National Library of Medicine)

state of florida doh central pharmacy - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen sodium 550 mg - carefully consider the potential benefits and risks of naproxen sodium tablets, usp and other treatment options before deciding to use naproxen sodium tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. naproxen as naproxen sodium tablets are indicated: • for the relief of the signs and symptoms of rheumatoid arthritis • for the relief of the signs and symptoms of osteoarthritis • for the relief of the signs and symptoms of ankylosing spondylitis • for the relief of the signs and symptoms of juvenile arthritis • for relief of the signs and symptoms of tendonitis • for relief of the signs and symptoms of bursitis • for relief of the signs and symptoms of acute gout • for the management of pain • for the management of primary dysmenorrhea naproxen sodium tablets, usp are contrain

Stati Uniti - Ingliż - NLM (National Library of Medicine)

american regent, inc. - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue 5 mg in 1 ml - provayblue is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. provayblue is contraindicated in the following conditions: - severe hypersensitivity reactions to methylene blue or any other thiazine dye [see warnings and precautions (5.2)] . - patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia [see warnings and precautions (5.3, 5.4)]. risk summary provayblue may cause fetal harm when administered to a pregnant woman. intra-amniotic injection of pregnant women with a methylene blue class product during the second trimester was associated with neonatal intestinal atresia and fetal death. methylene blue produced adverse developmental outcomes in rats and rabbits when administered orally during organogenesis at doses at least 32 and 16 times, respectively, the clinical dose of 1 mg/kg (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions intra-amniotic injection of a methylene blue class product hours to days prior to birth can result hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress and photosensitivity in the newborn. following administration of provayblue to a pregnant woman at term, observe the newborn for these adverse reactions and institute supportive care. data animal data methylene blue was administered orally to pregnant rats at doses of 50 to 350 mg/kg/day, during the period of organogenesis. maternal and embryofetal toxicities were observed at all doses of methylene blue and were most evident at the 200 and 350 mg/kg/day doses. maternal toxicity consisted of increased spleen weight. embryo-fetal toxicities included reduced fetal weight, post-implantation loss, edema, and malformations including enlarged lateral ventricles. the dose of 200 mg/kg (1200 mg/m2 ) in rats is approximately 32 times a clinical dose of 1 mg/kg based on body surface area. methylene blue was administered orally to pregnant rabbits at doses of 50, 100, or 150 mg/kg/day, during the period of organogenesis. maternal death was observed at the methylene blue dose of 100 mg/kg. embryofetal toxicities included spontaneous abortion at all dose levels and a malformation (umbilical hernia) at the 100 and 150 mg/kg/day doses. the dose of 50 mg/kg (600 mg/m2 ) in rabbits is approximately 16 times a clinical dose of 1 mg/kg based on body surface area. risk summary there is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions including genotoxicity, discontinue breast-feeding during and for up to 8 days after treatment with provayblue [see clinical pharmacology (12.3)] . the safety and effectiveness of provayblue for the treatment of acquired methemoglobinemia have been established in pediatric patients. use of provayblue is supported by two retrospective case series that included 2 pediatric patients treated with provayblue and 12 treated with another methylene blue class product. the case series included pediatric patients in the following age groups: 3 neonates (less than 1 month), 4 infants (1 month up to less than 2 years), 4 children (2 years up to less than 12 years), and 3 adolescents (12 years to less than 17 years). the efficacy outcomes were consistent across pediatric and adult patients in both case series [see clinical studies (14)]. clinical studies of provayblue did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. provayblue is known to be substantially excreted by the kidney, so the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, treatment of methemoglobinemia in these patients should use the lowest number of doses needed to achieve a response [see dosage and administration (2)] . methylene blue concentrations increased in subjects with renal impairment (egfr 15 to 89 ml/min/1.73m2 ) significantly [see clinical pharmacology (12.3)] . adjust provayblue dosage in patients with moderate or severe renal impairment (egfr 15 to 59 ml/min/1.73 m2 ) [see dosage and administration (2.2)] . no dose adjustment is recommended in patients with mild renal impairment (egfr 60 – 89 ml/min/1.73 m2 ). methylene blue is extensively metabolized in the liver. monitor patients with any hepatic impairment for toxicities and potential drug interactions for an extended period of time following treatment with provayblue.

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

flynn pharma ltd - phenytoin sodium - oral capsule - 300mg

Stati Uniti - Ingliż - NLM (National Library of Medicine)

physicians total care, inc. - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium 0.125 mg - levothyroxine sodium is used for the following indications: as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. in the treatment or prevention of various types of euthyroid goiters (see warnings and precautions), including thyroid nodules (see warnings and precautions), subacute or chronic lymphocytic thyroiditis (hashimoto’s thyroiditis), multinodular goiter (see warnings and precautions) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well different

Stati Uniti - Ingliż - NLM (National Library of Medicine)

state of florida doh central pharmacy - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium 25 ug - levothyroxine sodium is used for the following indications: as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. in the treatment or prevention of various types of euthyroid goiters (see warnings and precautions), including thyroid nodules (see warnings and precautions), subacute or chronic lymphocytic thyroiditis (hashimoto’s thyroiditis), multinodular goiter (see warnings and precautions) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well differentiated thyroid

Stati Uniti - Ingliż - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo), naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. limitations of use: - use only if a clear diagnosis of migraine headache has been established. if a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks. - sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks. - safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache. sumatriptan and naproxen sodium tablets are contraindicated in the following patients: - ischemic coronary artery disease (cad) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including prinzmetal’s angina [see warnings and precautions (5.1)]. - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] . - wolff-parkinson-white syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see warnings and precautions (5.3)]. - history of stroke or transient ischemic attack (tia) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see warnings and precautions (5.5)]. - peripheral vascular disease [see warnings and precautions (5.6)]. - ischemic bowel disease [see warnings and precautions (5.6)]. - uncontrolled hypertension [see warnings and precautions (5.8)]. - recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-ht1) agonist [see drug interactions (7)]. - concurrent administration of a monoamine oxidase (mao)-a inhibitor or recent (within 2 weeks) use of an mao-a inhibitor [see drug interactions (7), clinical pharmacology (12.3)]. - history of asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.13, 5.14, 5.18)]. - known hypersensitivity (e.g., anaphylactic reactions, angioedema, and serious skin reactions) to sumatriptan, naproxen, or any components of sumatriptan and naproxen sodium tablets [see warnings and precautions (5.14)]. - severe hepatic impairment [see warnings and precautions (5.7), use in specific populations (8.7), clinical pharmacology (12.3)]. risk summary use of nsaids, including sumatriptan and naproxen sodium tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of sumatriptan and naproxen sodium tablets use between about 20 and 30 weeks of gestation, and avoid sumatriptan and naproxen sodium tablets use at about 30 weeks of gestation and later in pregnancy (see clinical considerations, data ). premature closure of fetal ductus arteriosus use of nsaids, including sumatriptan and naproxen sodium tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. data from observational studies regarding other potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see human data ). in animal studies, administration of sumatriptan and naproxen, alone or in combination, during pregnancy resulted in developmental toxicity (increased incidences of fetal malformations, embryofetal and pup mortality, decreased embryofetal growth) at clinically relevant doses (see animal data ). based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as naproxen sodium resulted in increased pre- and post-implantation loss. prostaglandins also have been shown to have an important role in fetal kidney development. in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. fetal/neonatal adverse reactions premature closure of fetal ductus arteriosus: avoid use of nsaids in women at about 30 weeks gestation and later in pregnancy, because nsaids, including sumatriptan and naproxen sodium tablets, can cause premature closure of the fetal ductus arteriosus (see data ). oligohydramnios/neonatal renal impairment: if an nsaid is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. if sumatriptan and naproxen sodium tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue sumatriptan and naproxen sodium tablets and follow up according to clinical practice (see data ). labor or delivery there are no studies on the effects of naproxen tablets during labor or delivery. in animal studies, nsaids, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data human data there is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor, there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, and intracranial hemorrhage. naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction, and abnormal prostaglandin e levels in preterm infants. the sumatriptan/naratriptan/sumatriptan and naproxen sodium tablets (sumatriptan and naproxen sodium) pregnancy registry, a population-based international prospective study, collected data for sumatriptan from january 1996 to september 2012. the registry included only 6 pregnancy exposures to sumatriptan and naproxen sodium tablets, with no major birth defects reported. the registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). the occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% ci: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% ci: 2.7% to 6.2%]). the sample size in this study had 80% power to detect at least a 1.73- to 1.91-fold increase in the rate of major malformations. the number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or to support making comparisons of the frequencies of specific birth defects. of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis. no other birth defect was reported for more than 2 infants in this group. in a study using data from the swedish medical birth register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% ci: 0.91 to 1.21]). a study using linked data from the medical birth registry of norway to the norwegian prescription database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (or 1.16 [95% ci: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (or 1.83 [95% ci: 1.17 to 2.88]), each compared with the population comparison group. additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. premature closure of fetal ductus arteriosus: published literature reports that the use of nsaids at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment: published studies and postmarketing reports describe maternal nsaid use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. these adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after nsaid initiation. in many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. there have been a limited number of case reports of maternal nsaid use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. these limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal nsaid use. because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to nsaids through maternal use is uncertain. animal data oral administration of sumatriptan alone to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. the highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day, or approximately 3 times the maximum recommended human dose (mrhd) of 170 mg/day on a mg/m2 basis. oral administration of sumatriptan alone to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryolethality and fetal cervicothoracic vascular and skeletal abnormalities. intravenous administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryolethality. the highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 (approximately 2 times the mrhd on a mg/m2 basis) and 0.75 mg/kg/day, respectively. oral administration of sumatriptan combined with naproxen sodium (5/9 mg/kg/day, 25/45 mg/kg/day, or 50/90 mg/kg/day sumatriptan/naproxen sodium) or each drug alone (50/0 mg/kg/day, 0/90 mg/kg/day sumatriptan/naproxen sodium) to pregnant rabbits during the period of organogenesis resulted in increased total incidences of fetal abnormalities at all doses and increased incidences of specific malformations (cardiac interventricular septal defect in the 50/90 mg/kg/day group, fused caudal vertebrae in the 50/0 mg/kg/day and 0/90 mg/kg/day groups) and variations (absent intermediate lobe of the lung, irregular ossification of the skull, incompletely ossified sternal centra) at the highest dose of sumatriptan and naproxen alone and in combination. a no-effect dose for developmental toxicity in rabbit was not established. the lowest effect dose of 5/9 mg/kg/day sumatriptan/naproxen sodium was associated with plasma exposures (auc) to sumatriptan and naproxen that were less than those attained at the mrhd of 170 mg sumatriptan and 1,000 mg naproxen sodium (two tablets of sumatriptan and naproxen sodium tablets 85/500 mg in a 24-hour period). oral administration of sumatriptan alone to rats prior to and throughout gestation resulted in embryofetal toxicity (decreased body weight, decreased ossification, increased incidence of skeletal abnormalities). the highest no-effect dose was 50 mg/kg/day, or approximately 3 times the mrhd on a mg/m2 basis. in offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. the highest no-effect dose for this effect was 60 mg/kg/day, or approximately 3 times the mrhd on a mg/m2 basis. oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. the highest no-effect dose for this finding was 100 mg/kg/day, or approximately 6 times the mrhd on a mg/m2 basis. in reproduction studies of naproxen in rats (20 mg/kg/day), rabbits (20 mg/kg/day, and mice (170 mg/kg/day, no evidence of impaired fertility or harm to the fetus was observed. the doses tested in rats, rabbits, and mice were less (≤0.8 times) the mrhd, based on body surface area (mg/m2 ) comparisons. risk summary the naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. sumatriptan is excreted in human milk following subcutaneous administration (see data ). there is no information regarding sumatriptan concentrations in milk from lactating women following administration of sumatriptan tablets. there are no data on the effects of naproxen or sumatriptan on the breastfed infant or the effects of naproxen or sumatriptan on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sumatriptan and naproxen sodium tablets and any potential adverse effects on the breastfed infant from sumatriptan and naproxen sodium tablets or from the underlying maternal condition. clinical considerations infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with sumatriptan tablets. data following subcutaneous administration of a 6-mg dose of sumatriptan injection in 5 lactating volunteers, sumatriptan was present in milk. infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including naproxen tablets, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including naproxen tablets, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness of sumatriptan and naproxen sodium tablets in pediatric patients under 12 years of age have not been established. the safety and efficacy of sumatriptan and naproxen sodium tablets for the acute treatment of migraine in pediatric patients 12 to 17 years of age was established in a double-blind, placebo-controlled trial [see adverse reactions (6.1) and clinical studies (14.2)] . elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. sumatriptan and naproxen sodium tablets are not recommended for use in elderly patients who have decreased renal function, higher risk for unrecognized cad, and increases in blood pressure that may be more pronounced in the elderly [see warnings and precautions (5.1, 5.2, 5.3, 5.8,5.12) and clinical pharmacology (12.3)] . a cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of cad) prior to receiving sumatriptan and naproxen sodium tablets [see warnings and precautions (5.1)] . sumatriptan and naproxen sodium tablets are not recommended for use in patients with creatinine clearance less than 30 ml/min. monitor the serum creatinine or creatinine clearance in patients with mild (crcl = 60 to 89 ml/min) or moderate (crcl = 30 to 59 ml/min) renal impairment, preexisting kidney disease, or dehydration [see warnings and precautions (5.12)and clinical pharmacology (12.3)] . sumatriptan and naproxen sodium tablets are contraindicated in patients with severe hepatic impairment.